Coronavirus | Dr. Reddy’s leads emergency approval process for Sputnik V. a
Sputnik V is one of only three vaccines worldwide with an efficacy of 91.6% and has the most approvals in 26 countries worldwide, according to the company.
Dr. Reddy’s Laboratories Ltd. announced on Friday that it has initiated the process with the Drugs Controller General of India (DCGI) for the Emergency Use Authorization (EUA) of the human adenoviral vector-based platform vaccine candidate Sputnik V.
“As part of the review process, Dr. Reddy’s will present the safety profile of the phase II study as well as interim data from the phase III study, which is expected to be completed on February 21, 2021, ”the company said in a statement.
Coronavirus | Sputnik V COVID-19 Vaccine Shows 91% Efficacy Meanwhile
GV Prasad, Co-Chairman and Managing Director of Dr. Reddy’s Laboratories said, “The effectiveness of Sputnik V was found to be 91.6% of the time The lancet, an impressive development in the fight against COVID-19. The initiation of the EEA process will be a decisive step forward for us to ensure rapid access to the Sputnik-V vaccine in India. “
Sputnik V, developed by the National Research Institute for Epidemiology and Microbiology Gamaleya, was registered by the Russian Ministry of Health on August 11, 2020 and became the world’s first registered vaccine against COVID-19 based on the human adenoviral vector platform.
Read: Sputnik-V vaccine expected to start in March
“More than 250 clinical studies spanning two decades have demonstrated the safety, efficacy and the absence of long-term negative effects of adenoviral vaccines. Sputnik V is one of only three vaccines worldwide with an efficacy of 91.6% and has the most approvals in 26 countries worldwide. The vaccine has already been given to more than 2 million people worldwide, ”the statement said.
It also states that Dr. Reddy’s partnered with the Russian Direct Investment Fund (RDIF) in September 2020 to conduct the clinical trials of Sputnik V and its distribution rights in India.
“The vaccine is currently in the Phase 3 clinical trial in India. Sputnik V has demonstrated an efficacy rate of 91.6% in the interim analysis of the Phase 3 clinical trial, which included data from 19,866 volunteers in Russia who received both the first and second doses of the vaccine. Sputnik V maintained a constant effectiveness of 91.8% even in the group of 2,144 volunteers over 60 years of age, ”says the company.